Authorised Representative (AR) Consultant
Utrecht (32-40 hrs)
Our client is a specialized consultancy supporting medical device manufacturers with regulatory compliance and quality management across Europe. They are currently seeking an experienced Medical Device Consultant to join their team and help clients navigate the evolving European Medical Device Regulations (EU MDR).
What You'll Do
- Advise medical device companies on implementing EU MDR requirements.
- Create, review, and manage technical documentation.
- Implement and maintain ISO 13485-compliant Quality Management Systems.
- Stay current with regulatory changes and industry standards to ensure compliance.
What You Bring
- Minimum 3 years of experience in the medical device industry, healthcare, or related services.
- Strong understanding of QMS for medical devices.
- Bachelor's degree in life sciences, technology, or biochemistry.
- Fluent in Dutch (Requirement).
Preferred Experience
- Background in quality or regulatory affairs management.
- Experience as a (lead) auditor for MDR or ISO 13485.
- Familiarity with international enterprises and regulatory bodies.
What's Offered
- A competitive salary between 60k and 90k.
- Professional yet informal work culture.
- Flexibility in work arrangements and travel.
Does this job sound promising to you?